Trial Outcomes & Findings for Impact of Prisma on Donor Site Pain (NCT NCT04050124)
NCT ID: NCT04050124
Last Updated: 2024-04-16
Results Overview
Pain score is measured using a VAS ranging from 0-10, where 0 = no pain and 10 = unbearable pain. Participants select the number that best reflects their current status. The total score is the numerical response; lower scores indicate lower pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Postoperative Day 1
Results posted on
2024-04-16
Participant Flow
Participant milestones
| Measure |
Promogran Prisma
Following standard of care split thickness skin grafting, patients randomized to the intervention group will receive Promogan Prisma as the primary contact dressing at the donor grafting site.
Promogran Prisma: Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix
|
Standard of Care (SOC) Dressings
Standard of care (SOC) dressings: standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Promogran Prisma
Following standard of care split thickness skin grafting, patients randomized to the intervention group will receive Promogan Prisma as the primary contact dressing at the donor grafting site.
Promogran Prisma: Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix
|
Standard of Care (SOC) Dressings
Standard of care (SOC) dressings: standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Impact of Prisma on Donor Site Pain
Baseline characteristics by cohort
| Measure |
Promogran Prisma
n=7 Participants
Following standard of care split thickness skin grafting, patients randomized to the intervention group will receive Promogan Prisma as the primary contact dressing at the donor grafting site.
Promogran Prisma: Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix
|
Standard of Care (SOC) Dressings
n=9 Participants
Standard of care (SOC) dressings: standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.5 years
n=5 Participants
|
69.55 years
n=7 Participants
|
69.88 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative Day 1Pain score is measured using a VAS ranging from 0-10, where 0 = no pain and 10 = unbearable pain. Participants select the number that best reflects their current status. The total score is the numerical response; lower scores indicate lower pain.
Outcome measures
| Measure |
Promogran Prisma
n=7 Participants
Following standard of care split thickness skin grafting, patients randomized to the intervention group will receive Promogan Prisma as the primary contact dressing at the donor grafting site.
Promogran Prisma: Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix
|
Standard of Care (SOC) Dressings
n=9 Participants
Standard of care (SOC) dressings: standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.
|
|---|---|---|
|
Pain Score on Visual Analogue Scale (VAS)
|
2 score on a scale
Interval 0.0 to 8.0
|
2 score on a scale
Interval 0.0 to 8.0
|
Adverse Events
Promogran Prisma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard of Care (SOC) Dressings
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place